BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEPGEN P-15

    MDR report key: 4961207 · Received July 29, 2015

    Report

    Report Number
    2320721-2015-00008
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    November 26, 2014
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    NPZ
    PMA / PMN Number
    P990033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE INTERVENTION WAS REQUIRED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT PEPGEN P-15 BONE GRAFTING MATERIAL PULLED AWAY FROM THE EXTRACTION SOCKET WALL IN A PATIENT. THE DENTIST REMOVED THE MATERIAL AND COMPLETED THE PROCEDURE USING ANOTHER BONE GRAFTING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492383 PEPGEN P-15 BONE GRAFTING MATERIAL NPZ DENTSPLY TULSA DENTAL SPECIALTIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention